Bedford Document Change Procedure

Document Number Revision Revision Date Page

SOP-00001 F July 27, 2023 1 of 5

1. Scope
1.1. The document control process will apply to all product documents and drawings, fixture
drawings, and software that are under revision control within the Bedford MA facility.
2. Associated Documents
2.1. QAP-00002 Document Control
2.2. FRM-00009 Engineering Change Order Request Form (ECO)
3. Definitions and Acronyms
3.1. MPR Manufacturing Procedures
3.2. MPM Maintenance Procedures
3.3. PS Product Specifications
3.4. ECO Engineering Change Order
3.5. CCB Change Control Board
3.6. BOM Bills of Material
3.7. SVN Revision Control System
3.8. PLM Product Life-cycle Management
3.9. COGS Cost of Goods Sold
4. Responsibilities
4.1. Document Control – Ensures the change process is executed in a timely manner and in
accordance with the steps described in this document. Provides final verification of ECO
implementation actions and completes final implementation of ECO.
Ensures any modified hardcopy documents previously issued to production have been
reviewed, re-issued and logged if applicable.
4.2. Originator – Over all owner of ECO. Responsible to see ECO to completion and to notify doc
control upon completion of all pre/post implementation items.
4.3. Engineering – Verifies and validates design changes. Ensure the change is consistent with
design specifications. Initiates/modifies engineering documentation.
4.4. Manufacturing Engineering – Verifies and if necessary, validates manufacturing process
changes. Ensures the change is consistent with process specifications and capacity.
Initiates/modifies manufacturing documentation. Maintains point of use documentation on the
production floor.
4.5. Product Management – Notifies customer of changes if required. Reviews impact of COGS.
4.6. Quality – Ensures that changes requested are consistent with the Quality Management
System. Facilitates the CCB meetings.
4.7. Supply Chain – Responsible for material impact and lead time analysis if required.
4.8. Planning – Responsible for impact analysis to material in process and dispositioning.
4.9. Designee – A person designated as a backup by the assigned owner to review and sign on
their behalf.

Document for Internal Use Only. Printed documents are for reference only. Verify revision before use.
QAP/SOP Template FRM-00088 Rev A Revision Date: February 4, 2021
 Bedford Document Change Procedure
Document Number Revision Revision Date Page
SOP-00001 F July 27, 2023 2 of 5

5. Procedure
5.1. Document Control Principles
5.1.1. All documents under documentation control will be assigned a part number. The part
numbers and document descriptions will be organized and stored in a database. Documents
will be stored in electronic format in an easily searchable folder structure. BOMs will be
created and controlled by the documentation department and managed in an Enterprise
Resource Planning (ERP) system. Any part number that is sold by the company must be
entered into the ERP system.
Documents for products that are released to production will have alphabetical revisions
starting with Revision A when the document is released. Documents for prototypes will have
numerical revisions starting with Revision 1. Each document must be reviewed and signed
per Approval Matrix. If a document or drawing must be modified after it is put into document
control, an ECO must be issued and implemented by the documentation departments.
5.2. Part Number Management
5.2.1. Document Control is responsible for managing part numbers. A master database which lists
all part numbers with descriptions is maintained by the documentation department and
available to the organization. The master database shall be organized in a manner that is
easily searched.
5.3. Storage of documents
5.3.1. All documents, drawings and ECO packages will be retrievable and maintained by
Document Control.
5.3.1.1. All revision-controlled documents are stored in the engineering documents electronic
folder. See records section for location.
5.3.1.2. External documents are stored in the customers documents electronic folder. See
records section for location.
5.3.2. All documents used to aid production of products will are available at the point of use.
5.3.2.1. Documents that are kept and maintained at the point of use include, but are not limited
to, MPR, VAD, and AD documentation.
5.3.2.2. Once a new document has been released and stamped, the document at the point of
use is updated with the latest version and the old version removed.
5.3.2.3. A digital log of point of use documentation is maintained to show revision, number of
copies and date issued for each document. See record section for location.
5.4. Bill of Materials (BOMs)
5.4.1. BOMs are managed in the organization’s ERP system. BOM’s and associated part numbers
are entered and maintained in the ERP system by Document Control.
5.4.2. If upon review the CCB rejects an ECO, it will either be rejected or will be sent back to the
initiator for additional information.
5.5. Engineering Change Order (ECO)
5.5.1. The ECO is initiated by the originator via FRM-00009
5.5.2. The originator presents the ECO at the CCB meetings.
5.5.3. ECO FRM-00009 provides instructions on cross functional responsibilities and overall flow of
the ECO process.

Document for Internal Use Only. Printed documents are for reference only. Verify revision before use.
QAP/SOP Template FRM-00088 Rev A Revision Date: February 4, 2021
 Bedford Document Change Procedure
Document Number Revision Revision Date Page
SOP-00001 F July 27, 2023 3 of 5

5.5.4. If an ECO is rejected by the CCB, the reason for the reject is documented in FRM-00009 and
the partially completed form would be archived under the rejected ECOs folder – See records
section for folder location.
5.5.5. Once an ECO is approved at the CCB meeting a unique ECO number will be issued, and
an ECO package containing completed FRM-00009 and supporting documentation will be
created.
5.5.6. The resulting ECO package must be reviewed and signed off by cross functional leadership
as defined in FRM-00009.
5.5.6.1. The originator of an ECO is not an authorized signee
Approval Matrix below for ECO routings:
Form, Process Software Tooling Documentation Customer
Fit or Only Affected
Function
Engineering X X X X X
Manufacturing
X X X X X X
Engineering
Product Management X X
Operations X X X X X
Quality X X X X X X
Supply Chain X X X X X
Planning X X X X X
Sales X X
Finance Finance signature required if scrap or rework cost is in excess of $2500
EH&S EH&S signature required when involving the use of chemicals, changes or
addition of processes / procedures that impact employee’s health, safety or
environment.
5.5.7. Once an ECO is issued, affected items must undergo a change in revision. The ECO and
revision changes must be noted in the ERP system by Document Control.
5.5.8. When an ECO is fully implemented in the ERP system, Document Control will send an
email notification to all cross-functional teams.
5.6. Inactive / Obsolete Documents
5.6.1. Obsolete documents are segregated from active/current documents. Electronic master
files are stored in an archive within the change folder. The master list is update by changing
the description to indicate the item is obsolete and setting the status to inactive. If a part is
being obsoleted the change needs to be document in an ECO. The ERP status needs to
be updated to obsolete and all copies need to be archived. Once a part has been obsoleted
it may never be used again.
5.7. Software
5.7.1. Software associated with products and fixtures must be managed under the document
control system. The software source code shall be stored in SVN repository under revision
control. Software executable images are stored under ECO control and are defined through
a document under ECO control.
5.7.2. All updated software that are deployed must be stored in a controlled software location.

Document for Internal Use Only. Printed documents are for reference only. Verify revision before use.
QAP/SOP Template FRM-00088 Rev A Revision Date: February 4, 2021
 Bedford Document Change Procedure
Document Number Revision Revision Date Page
SOP-00001 F July 27, 2023 4 of 5

5.8. Hardcopy Documentation

5.8.1. All hardcopy documentation outside of the work order packet, must be stamped and logged
by Document Control or the Quality Manager if Document Control is unavailable.
5.9. Fixtures
5.9.1. Drawings and documents for production fixtures must be entered into the
document control system
• The fixture BOM will be listed and managed in tabular form on a high-level
assembly drawing rather than the ERP system
• Fixtures used only for design and development may be entered into the
document control system, but it is not a requirement.
6. Records
6.1. Record Location: Engineering Documents: \\trinity\Shared\Eng\Documents\Engineerings
PDF\Engineering Documents
External Documents: \\trinity\Shared\Eng\Documents\Engineerings PDF\Customer Documents
Point of use Documentation Log: S:\Eng\Documents\Engineerings PDF\Quality
Documents\Production Controlled Documents Log
6.2. Record Type: Electronic
6.3. Minimum Retention Period: 15 Years
6.4. Disposition of Records after Retention Period: Delete Electronic Record

Document for Internal Use Only. Printed documents are for reference only. Verify revision before use.
QAP/SOP Template FRM-00088 Rev A Revision Date: February 4, 2021
 Bedford Document Change Procedure
Document Number Revision Revision Date Page
SOP-00001 F July 27, 2023 5 of 5

7. Revision History
Revision Date Summary Record Control # Writer /
Reviser
A 1/10/2018 Initial Release DCO-000016 P. Baley
Updates based on process reboot from the
B 5/09/2019 DCO-000087 A. Harold
ECO Mapping Event
Update procedure to comply with the
C 10/29/2019 DCO-000244 D. Holmes
restructure of the document control process.
Updated various error corrections
Updates to reflect the new ECO process:
-Removed ECR process
-Modified approval matrix
D 10/8/2021 -Updates to responsibilities DCO-000358 J. Liu
-Prototypes no longer fall under ECO process
-Add links to key document locations
-Added software section 5.7.2 for software
control location
Added Hardcopy Documentation section
E 9/28/2022 Removed Prototype Documentation section. DCO-000410 A. Harold
Added EH&S sign off criteria
Updated Responsibility of Originator and
Manufacturing Engineering.
Added section 5.3.2 to address point of use
documentation.
F DCO-000464 S.Few
7/27/2023 Added 6.3 Record location for point of use
documentation. Added additional
requirements to OBS docs. Sect. 5.6.1.
Added Point of Use location in Sect. 6

Document for Internal Use Only. Printed documents are for reference only. Verify revision before use.
QAP/SOP Template FRM-00088 Rev A Revision Date: February 4, 2021